FDA-Device2018-05-09Class II

Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.

Siemens Healthcare Diagnostics, Inc.
Hazard

When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers

Sold states
FL and France Spain Sweden United Kingdom Germany
Affected count
N/A
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1586-2018

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